However, it put such great pressure that the companion diagnostics that were approved often had been mostly or totally ineffective at identifying clinical responders to the various therapies. That is because genomics/epigenomics are far too limited in scope to encompass the vagaries and complexities of human cancer biology.

Although any number of labs and techniques can detect mutant genes, this area of pharmacogenomics was ripe for proprietary tests, invented alongside the drug and owned by the drug developer and/or a partner in the diagnostics field. This business opportunity evolved as more drugs were approved with companion diagnostics.

Unfortunately, the introduction of these drugs has not been accompanied by specific predictive tests allowing for a rational and economical use of the drugs. Patients, physicians, insurance carriers, and the FDA should be calling for predictive tests that allow for rational and cost-effective use of these highly expensive drugs.

Given the technical and conceptual advantages of functional profiling assays, together with their performance and the modest efficacy of therapy prediction based on analysis of genome expression, there is reason for a renewal in their interest for optimized use of medical treatment of malignant disease.

If UVB exposure & ozone depletion were e cause of skin cancer those living close to equator wld be eaten alive with malignant melanoma…

In one study, people who “often” used sunscreen had 3.34 times as many melanomas as those who “never” slathered up.

So…go figure.